Adult Dosing

Overactive bladder

• Start 7.5 mg PO daily; can increase to 15 mg PO qd after 2 wks of starting therapy
• If on potent CYP3A4 inhibitors: Max: 7.5 mg/day

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency

• Hypersensitivity to any of the ingredients of the product
• Urinary retention
• Gastric retention
• Uncontrolled narrow-angle glaucoma

• N/A

Renal Dose Adjustment

• Renal impairment: No dose adjustments

Hepatic Dose Adjustment

• Mild impairment (Child Pugh A): No dose adjustments
• Moderate impairment (Child Pugh B): Max 7.5 mg/day
• Severe impairment (Child Pugh C): Avoid use

• Angioedema of the face, lips, tongue, and/or larynx have been reported with darifenacin. Discontinue therapy and institute appropriate therapy if angioedema associated with upper airway swelling involving tongue, hypopharynx, or larynx occurs
• It can cause constipation, urinary retention and blurred vision. Heat prostration (due to decreased sweating) can occur if the drug is used in a hot environment
• Use with caution in patients being treated for narrow-angle glaucoma and only where the potential benefits outweigh the risks
• Patients should be advised to avoid engaging in potentially dangerous activities such as driving and operating machinery

Cautions: Use cautiously in

• Hepatic impairment (refer dose adjustment section)
• Gastrointestinal obstructive disorders
• Decreased GI motility
• Severe constipation
• Ulcerative colitis
• Myasthenia gravis
• Controlled angle-closure glaucoma (requires careful monitoring)
• Bladder neck obstruction
• Geriatric patients
• Potent CYP3A4 inhibitors

Enablex interacts with :

	Aricept
	Aricept ODT
	Donepezil
	Exelon
	Galantamine
	Razadyne
	Razadyne ER
	Rivastigmine

Pregnancy Category:C

Breastfeeding: Safety unknown; is excreted in breastmilk of lactating rats. Manufacturer advises caution.

• CNS: Dizziness, asthenia
• EENT: Blurred vision, dry eyes
• GI: Constipation, dry mouth, dyspepsia, nausea, gastric retention, abdominal pain, diarrhea
• METABOLIC: Heat intolerance
• GU: Urinary retention, UTI
• MISC: Angioedema, hypersensitivity reactions, flu syndrome, accidental injury

• Anticholinergic; antagonizes bladder smooth muscle contraction by acting as a muscarinic receptor antagonist
• Extensively metabolized by liver; CYP450: 2D6; 3A4 substrate
• Renally excreted (60%); feces: 40%
• Half-life: 13-19 hrs

US Trade Name(s)

• Enablex

US Availability

Enablex

• ETABS: 7.5, 15 mg

Canadian Trade Name(s)

• Enablex

Canadian Availability

Enablex

• ETABS: 7.5, 15 mg

UK Trade Name(s)

• Emselex

UK Availability

Emselex

• ETABS: 7.5, 15 mg

Australian Trade Name(s)

• Enablex

Australian Availability

Enablex

• ETABS: 7.5, 15 mg

[Outline]

Urologic

Antispasmodics; Urinary

Obstetrics/Gynecology

Antispasmodics; Urinary

Pricing data from www.DrugStore.com in U.S.A.

• Enablex 15 MG TB24 [Bottle] (WARNER CHILCOTT PROF PROD DIV)
  30 mg = $163.99
  90 mg = $465.96
• Enablex 7.5 MG TB24 [Bottle] (WARNER CHILCOTT PROF PROD DIV)
  30 mg = $164.99
  90 mg = $477.99

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Drug Name: 24 HR Enablex 7.5 MG Extended Release Tablet

Ingredient(s): Darifenacin

Imprint: N/A

Color(s): White

Shape: Round

Size (mm): 8.00

Score: 1

Inactive Ingredient(s): anhydrous dibasic calcium phosphate / hypromellose / polyethylene glycol / magnesium stearate / titanium dioxide / talc

Drug Label Author:
Novartis Pharmaceuticals Corporation

DEA Schedule:
Non-Scheduled

Drug Name: Enablex 15 MG 24 HR Extended Release Tablet

Ingredient(s): Darifenacin

Imprint: DF;15

Color(s): Orange

Shape: Round

Size (mm): 8.00

Score: 1

Inactive Ingredient(s): anhydrous dibasic calcium phosphate / ferric oxide red / hypromellose / polyethylene glycol / magnesium stearate / titanium dioxide / talc / ferric oxide yellow

Drug Label Author:
Novartis Pharmaceuticals Corporation

DEA Schedule:
Non-Scheduled